Priority-setting regarding offshore substances and preparations

3. Pre-screening of offshore chemicals

3.1 Procedures for pre-screening

In this chapter, the procedures developed for pre-screening of offshore chemicals are described.

3.1.1 Purpose

The purpose of the pre-screening is to divide the offshore chemicals into three groups. The three groups are defined as:

	Group 1. Chemicals having an unacceptable impact on the environment or on human health and which should therefore be considered for phasing out or substitution
	Group 2. Chemicals that may have a deleterious impact on the environment or on human health and which should therefore be further evaluated (e.g. by using the CHARM-model or other suitable procedures)
	Group 3. Chemicals that are considered to be of low hazard to the environment and to human health. The chemicals in this group are regarded as acceptable alternatives for chemicals that should be phased out (group 1 chemicals

3.1.2 General procedure for pre-screening

The PROSPECT pre-screening process is a stepwise procedure with focus on the environmental and occupational health aspects. The pre-screening is based solely on the inherent properties of the chemicals.

The primary information used is the classification of the substances and preparations regarding physico-chemical, human health and environmental hazards. Throughout the present report, the definition of preparations specified in the EU Classification Directive (67/548/EEC) applies, i.e. "preparations" means mixtures or solutions composed of two or more substances.

No criteria for classifying preparations with regard to environmental hazards are yet implemented and therefore, the hazards of the individual substances in the preparations are considered. The evaluation of the occupational health hazards is based on the human health hazard classification of the preparations. The classification of the preparations is based on the human health hazards (classification) of the individual substances in the preparations. Suppliers of chemical preparations are responsible for their correct classification.

An offshore chemical is usually composed of several different substances. These substances cannot be expected to distribute similarly in the environment and to have the same effects on the organisms. Therefore, the first step in the procedure is to evaluate the individual substances in the chemical. Substances are evaluated according to environmental criteria only and are placed in one of the following groups:

	Group S1
	Group S2
	Group S3

Substances that cannot be evaluated because of shortage of data, are placed on a waiting list. If more data on environmental hazards become available, the substances on the waiting list may be evaluated further.

The environmental hazards of preparations are evaluated according to the content of hazardous substances in the preparation. The preparation is placed in one of the following groups:

	Group P1 (E)
	Group P2 (E)
	Group P3 (E)

Waiting list

Preparations that cannot be evaluated because of shortage of data on the environmental properties of the individual substances, will be placed on a waiting list. If more data on their environmental hazards are obtained, the preparations may be evaluated further.

The occupational health hazards are also considered in the evaluation of preparations for substitution possibilities, resulting in the final placement in one of the following groups:

	Group P1 (H)
	Group P2 (H)
	Group P3 (H)

3.1.3 Criteria for grouping of substances

The criteria are based on information on the inclusion of the substances in a high priority list and on the inherent properties of the substances as expressed by the EU hazard classification system regarding the aquatic environment.

Substances belonging to group S1 are those included in high priority lists of very hazardous substances or those which are considered very hazardous to the aquatic environment according to their inherent properties. Substances fulfilling one of the criteria below should be considered for phasing out from actual use in offshore activities.

	Substances included in high priority lists of very hazardous substances (e.g. the EU list I, North Sea list 1A, Esbjerg declaration list, Helsinki Commission and Convention lists, cf. Appendix 1, Danish EPA’s List of Undesirable Substances).
	Substances classified as dangerous to the aquatic environment and assigned one of the following risk phrases (cf. Annex I to Directive 67/578/EEC):
	R50 (very toxic to aquatic organisms)
	R50/R53 (very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment)

or which according to the formal criteria for environmental hazard classification (cf. Annex VI to Directive 67/548/EEC (EC 1996)) should be assigned one of these risk phrases.

Substances that are considered to be of low hazard to the aquatic environment according to information on their inherent properties, are placed in group S3 according to either of the following criteria:

	Substances that according to the criteria for environmental hazard classification shall not be classified as dangerous to the aquatic environment.
	Substances on the list of substances/preparations used and discharged offshore (PARCOM offshore list A).

Placement of substances in group S2

Substances, for which available data indicate that they do not belong to either group S1 or group S3, are placed in group S2.

Substances for which sufficient information on inherent environmental properties is not available, are placed on a waiting list. Additional data must be obtained before a further evaluation and grouping can take place.

3.1.4 Criteria for grouping of preparations

Preparations are grouped into one of 3 groups during a two step procedure comprising an evaluation of their environmental hazards and an evaluation of their occupational health hazards. The specific criteria for grouping of the preparations are outlined below.

Placement of preparations in group P1(E)

Preparations are placed in group P1(E) according to the criterion below. These preparations are regarded as very harmful to the aquatic environment.

Preparations containing one or more group S1 substances

Placement of preparations in group P3(E)

Preparations fulfilling the below criterion are placed in group P3(E). These preparations are considered to be of low hazard to the aquatic environment.

Preparations only containing group S3(E) substances

Placement of preparations in group P2(E)

Preparations, for which data on environmental hazards indicate that they do not belong to either group P1(E) or P3(E), are placed in group P2(E).

Placement of preparations on a waiting list

Preparations that cannot be evaluated because of lack of data on one or more of the substances contained therein, are placed on a waiting list until enough relevant data are obtained.

Placement of preparations in group P1(H)

Preparations belonging to group P1(H) are those which are considered very hazardous to human health according to their inherent properties. Preparations fulfilling one of the criteria below should be considered for inclusion in group P1(H).

Preparations that have chronic or severe occupational health effects according to the EU classification system (EC 1996). The following classification/labelling applies:
Carcinogenic:	T;R45 or R49 or Xn;R40
Reproduction toxic:	T;R60 or R61 or Xn;R62 or R63
Mutagenic:	T;R46 or Xn;R40
Acutely toxic effects:	Tx;R26 or R27 or R28 or R39
T; R23 or R24 or R25 or R39 or R48

Placement of preparations in group P3(H)

Preparations fulfilling the below criterion are placed in group P3(H). These preparations are considered to be of low hazard to human health.

Preparations that according to the criteria for human health hazard classification shall not be classified as dangerous.

Placement of preparations in group P2(H)

Preparations, for which data on human toxicity indicate that they do not belong to either group P1(H) or P3(H), are placed in group P2(H).

For human health effects, this means that preparations that are or should be classified with the following risk phrases are placed in group P2(H):

3.1.5 Final grouping of preparations

The final grouping of preparations is based on a balancing of the environmental hazards with the occupational health hazards. In this assessment, possible precautions to be made to protect humans to exposure of the substance or preparation are included.

In general, the most severe grouping of the preparation will be decisive for the balanced placement of the preparation in one of the groups P1, P2 or P3. For example, a preparation grouped as P1(E) and P3(H) will be placed in group P1. However, considering that many preparations cannot be grouped on the basis of the environmental hazard criteria and therefore are placed on a waiting list, such preparations need to be handled separately. If a waiting list preparation is grouped in P1(H), it will be grouped as P1. If it is grouped in P2(H), it will be preliminarily grouped in a special group P2* in order to indicate that when more data on environmental properties become available, a more severe grouping may be necessary. Finally, if the waiting list preparation is grouped in P3(H), it is retained on a waiting list until more data become available. An overview of this grouping system is given in Table 3.1.

3.1.6 Example of grouping of a preparation

In order to illustrate the basic principles for grouping of preparations, the evaluation of a theoretical corrosion inhibitor is described. The theoretical composition of the preparation is given in Table 3.2 below:

Ethylene glycol

Ethylene glycol is readily biodegradable, has a log P_ow of about 0 although a bioconcentration factor of 190 has been determined with algae, and has a very low toxicity (LC50 > 1000 mg/l) towards aquatic organisms. The substance shall not be classified as dangerous for the aquatic environment and consequently, it is placed in group S3.

Tall oil

Tall oil is readily biodegradable, has a log P_ow of 0.3-5.5 and is therefore potentially bioaccumulative, and has a very low toxicity (LC50 > 1000 mg/l) towards aquatic organisms. The substance shall not be classified as dangerous for the aquatic environment and consequently, it is placed in group S3.

Hydrotreated light petroleum distillates are not readily biodegradable, are potentially bioaccumulative with a log P_ow of 1.5-5.7, and are toxic to various fish species with LC50 values in the range 2.4-5.9 mg/l. The data correspond to an environmental hazard classification of N; R51/53 (toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment) and the substance is therefore grouped in S2.

NPEO

Nonylphenol ethoxylate is not readily biodegradable and have acute toxicities towards various aquatic organisms in the range 1-1000 mg/l. The data correspond to an environmental hazard classification of N; R51/53 (toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment) and the substance should therefore be grouped in S2. However, because of the hormone-like effects of the substance, it is included in the Esbjerg Declaration list of substances that shall be substituted by less hazardous substances. It is therefore grouped in S1.

As the preparation contains a S1 substance, namely nonylphenol ethoxylate, it is placed in preparation group P1(E) covering chemicals that should be considered for phasing out or substitution.

Human health effects

Hydrotreated light petroleum distillates are classified as Xn;R65 (Harmful: may cause lung damage if swallowed). None of the other substances should be classified regarding human health hazards. As the kinematic viscosity of the preparation is probably above 7 mm²/sec, the preparation shall not be classified as dangerous to the human health. The preparation is therefore placed in group P3 (H).

Because of the placement in group P1(E), the final grouping will be P1.

3.2 Data collection

Data on offshore chemicals used in the Danish sector of the North Sea were obtained from the suppliers via the NSOC-D and from the Danish Products Registration Office. In general, the data from the suppliers were submitted in the HOCNF but very often additional information on composition as well as on the properties of the chemicals was requested because the submitted data were incomplete.

Additional information on the ecotoxicological properties of the substances contained in the offshore chemicals was collected from a few relatively easily available data sources. A list of the data sources is given in Table 3.3 and additional data sources are listed in Appendix 2:

3.3 Development of database

The PROSPECT database was established in order to facilitate the data handling. The database system was developed in the database program Paradox.

An overview of the structure of the PROSPECT database is given in Figure 3.1.

A User Manual has been prepared in which the facilities of the program are described.

The database contains confidential information on formulation of offshore chemicals and is therefore not available to the public but only for the Danish EPA and the Danish Products Registration Office. For further information, please contact the Danish EPA.

3.4 Results of the pre-screening

In total, 273 offshore preparations containing 306 substances were evaluated by use of the pre-screening criteria described in Section 3.1.

3.4.1 Substances

The pre-screening was initiated by evaluating the environmental properties of the individual substances present in the offshore preparations. The number of substances grouped into the 4 categories (S1, S2, S3, WL) according to the above criteria regarding hazard to the aquatic environment is shown in Table 3.4.

Category S1

24 substances have been grouped into category S1:

	13 of the 24 substances are proposed to be classified with the risk phases N;R50 or N;R50/53 with regard to environmental danger
	8 of the 24 substances are on the Esbjerg declaration lists on substances to be phased out (alkylphenol or alkylphenol ethoxylates which shall probably be classified with N;R51/53 but which are additionally suspected to have estrogen-like effects on reproduction)
	3 of the 24 substances are on the EU list I although they should be classified with N;R51/53, R52/53 and not classified with regard to environmental danger, respectively, according to the formal criteria for environmental hazard classification (EC 1996).

Category S2

31 substances were grouped into S2:

	12 of the 31 are proposed to be classified with N;R51/53 with regard to environmental danger
	17 of the 31 substances are proposed to be classified with R52/53 with regard to environmental danger
	2 of the 31 substances are proposed to be classified with R53 with regard to environmental danger

Substance waiting list

For a relatively large proportion of the substances (40 %), an evaluation was not possible due to lack of data on one or more of the properties. However, as only a few relatively easily available data sources were consulted, a more thorough data collection would probably move several of the substances on the WL into one of the 3 categories S1, S2 or S3. It was, however, not the intention of the project to make a thorough data collection on ecotoxicological properties of all chemicals identified in offshore preparations.

3.4.2 Preparations

Based on the grouping of the substances into the 4 categories, the preparations were grouped according to the criteria regarding hazard to the aquatic environment (cf. Section 3.1.4). Based on their health hazard classification, the preparations were also grouped according to the criteria specified in Section 3.1.4. An overview of the grouping of the preparations is given in Table 3.5.

Based on this grouping, the final placement of each preparation is made according to the criteria described in Section 3.1.5, i.e. the most severe category determines the grouping. When a preparation is placed in P2 due to health criteria, but WL due to lack of data on environmental properties, it is placed in P2* to indicate that new data on environmental properties might result in a severe grouping. The resulting final placement is shown in Table 3.6 in which also the reason for the grouping is shown.

P2*: Substances assigned P2 (health) and WL (environment)

Despite the relatively large number of substances that could not be grouped regarding environmental hazard due to lack of data (40%), most of the preparations (240 corresponding to 88%) could be assigned a category. Of these, however, 33 (12%) were preliminarily placed in P2* based solely on human health hazards as no sufficient data on environmental hazards were available. For 32 preparations (12%), the hazard to the environment was decisive for the placement, for 114 preparations (42%), the human health hazards were decisive, and for 94 preparations (34%), both environmental and human health properties were decisive. These aspects are described in more detail below.

It follows from the above Table 3.6 that 35 preparations (13%) are placed in the most severe group (P1). The health hazard classification was only decisive for grouping of 7 of those chemicals.

Category P1

Of the 28 preparations grouped in category P1 due to environmental hazards, 20 preparations contain substances that are grouped into S1 because they should be classified with N;R50 or N;R50/53, 11 contain substances covered by the Esbjerg declaration, and 2 contain substances included in the EU list I. Note that some of the preparations contain more than one substance from S1.

13 preparations are grouped in P1 due to health hazards. One is to be classified with R45 (carcinogenic), 5 are classified R40 (carcinogenic or mutagenic) and 9 are classified with R23, R24, R25, R48 or combinations thereof (acutely toxic).

A list of the P1 preparations and information on the reason for the placing in group P1 are given in Appendix 3.

In principle, all P1 preparations should be subjects for phasing out plans. However, if a prioritisation is necessary, it should be based upon a more precise assessment of the risks to human health and the environment.

The human health risk assessment should combine the above hazard (effect) assessment and an exposure assessment. The latter should focus on the actual offshore use of the preparation, i.e. an assessment of the volume used, the risk of contact with the preparation, how a contact will take place, etc.

The environmental risk assessment could be an initial one where both the content of S1 substances in the preparation and the volume used could be taken into account. The content of S1 substances varies between the preparations from less than 1% to substantial amounts (more than 30-50%) and for one preparation 100% (zinc oxide). No information was collected on the volume used in the offshore industry of the category P1 preparations.

Category P2 and P2*

129 preparations corresponding to 48% of the preparations are placed in P2 and P2*. Of these, 33 are preliminarily grouped in P2* as only sufficient data on human health hazards are available. Only 22 preparations are included in P2 and P2* due to environmental hazards. 11 preparations contain substances proposed to be classified with N;R51/53 in amounts from 10 to 100%, and 11 preparations contain substances proposed to be classified with R52/53 or R53 in amounts from 16 to 100%.

119 preparations are grouped in P2 and P2* due to human health hazards (incl. 12 preparations that are also P2 due to environmental hazards). The classification of these are shown in Table 3.7 below. A relatively large number of these are classified due to more than one human health hazard. These preparations are represented more than once in Table 3.7.

It is evident that many of the preparations used offshore are corrosive and/or irritating as many are acids or bases.